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Simplified 510(k)s for radiation therapy, ultrasound, nuclear imaging rejected by FDA.

This article was originally published in The Gray Sheet

Executive Summary

SIMPLIFIED 510(K)S NIXED FOR RADIATION THERAPY, NUCLEAR AND ULTRASOUND imaging due to a lack of comprehensive standards for the devices, Joe Levitt, FDA Center for Devices and Radiological Health deputy director for regulations and policy, said Sept. 18 at the National Electrical Manufacturers Association annual meeting in Vail, Colorado. Levitt told NEMA members that FDA will not accept the association's proposal to allow simplified 510(k)s attesting compliance with voluntary standards because CDRH reviewers have concluded that the standards "get to part of your 510(k), not all."
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